| CTRI Number |
CTRI/2024/02/063284 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Sleep Pattern and its
Association with Stress among UG and PG
Medical Students in GMC bhavnagar |
|
Scientific Title of Study
|
Sleep Pattern and its
Association with Stress among UG and PG
Medical Students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kashish Mehta |
| Designation |
Resident |
| Affiliation |
GMC Bhavanagar, Sir T Hospital |
| Address |
Room No. 33, 6th floor, PG1, Sir T Hospital, Bhavnagar, Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9711087206 |
| Fax |
|
| Email |
mehta.kashish54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mukesh Patel |
| Designation |
Additional Professor |
| Affiliation |
GMC Bhavnagar, Sir T Hospital |
| Address |
B-202 ACE Riverside, AtmaNeem Nature Cure, Taraghadi, Rajkot
Rajkot
GUJARAT
360110
India |
| Phone |
9376623322 |
| Fax |
|
| Email |
dr.mkpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kashish Mehta |
| Designation |
Resident |
| Affiliation |
GMC Bhavnagar, Sir T Hospital |
| Address |
Psychiatry department, Sir T Hospital, Bhavnagar, Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9711087206 |
| Fax |
|
| Email |
mehta.kashish54@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir T Hospital, Bhavnagar, Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Kashish Mehta |
| Address |
Room no. 10, Psychiatry Department, Sir T Hospital, Bhavnagar, Gujarat |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kashish Mehta |
Sir T Hospital |
Psychiatry Department, GMC Bhavnagar Bhavnagar, Gujarat
Bhavnagar
GUJARAT |
9711087206
mehta.kashish54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government medical college,bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than or equal to 18 years.
Students who are willing to give informed written consent.
|
|
| ExclusionCriteria |
| Details |
Students having major psychiatric disorder (depression, bipolar mood disorder, schizophrenia, OCD, anxiety disorders and other psychotic disorders)
Pregnancy
Students fulfilling criteria of any substance dependence |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome is to know Sleep Pattern and its association with Stress among UG and PG Medical Students in GMC Bhavnagar
|
12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess sleeping pattern of UG & PG medical students in GMC Bhavnagar
To assess stress in UG & PG medical students in GMC Bhavnagar
To find association between stress & sleep pattern |
9 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Approval from ethics
committee of Government Medical College, Bhavnagar.
Students will be
included based on inclusion and exclusion criteria
Purpose of the study
would be explained to students and informed consent will be taken.
Data will be
collected through online questionnaires
Interview will be
requested if collected data suggests further clarification.
Appropriate
statistical analysis will be done according to collected data. The purpose of the
study is to know the sleep pattern and stress among the UG and PG medical
students of GMC Bhavnagar and its association. |